The disclosed invention relates generally to medical devices and more particularly to implants and less traumatic methods for delivering implants within a pelvic region of a patient to treat various pelvic dysfunctions.
A variety of medical procedures are performed to treat various female pelvic dysfunctions, including procedures to treat urinary incontinence, and correcting various prolapse conditions such as uterine prolapse, cystoceles, rectoceles, and vaginal vault prolapse.
Women often experience vaginal prolapses due to age or other factors. For example, women may experience a cystocele, a rectocele and/or a hysterocele. A cystocele occurs when the bladder bulges into the vagina, and a rectocele occurs when the rectum bulges into the vagina. A hysterocele occurs when the uterus descends into the vagina. An enterocele small bowel prolapse) can also occur, when the small bowel pushes through the upper wall of the vagina. It is relatively common for a hysterocele and cystocele or hysterocele and rectocele, or other combinations thereof to occur at the same time. It is also common for different types of prolapse to occur in relatively quick succession.
Treatment has included suturing procedures or the use of implants for support or suspension. A hysterocele is often treated with a hysterectomy followed by a vaginal vault suspension. Various devices and procedures are used to deliver and secure pelvic implants within a variety of different anatomical structures within a pelvic region. Implants can be delivered to a pelvic region through one or more vaginal incisions, and/or through exterior incisions in the patient.
Known methods of delivering or implanting implants, such as slings, within the body include the use sleeves. In such known methods, a sleeve is disposed about the implant during insertion such that the sleeve and the implant are inserted within a bodily tissue. The sleeve, with the implant inside, is inserted through a bodily tissue. Once the implant is, for example, in a desired positioned within the bodily tissue, the sleeve can be removed from the body leaving the implant disposed within the bodily tissue. The sleeve protects the tissue from abrasion by the implant during delivery and adjustment, and protects the implant from over-stretching during delivery. The use of such known sleeves during implantation, however, can result in trauma to the bodily tissue through which the sleeve and implant have been inserted. More specifically, the sleeve adds bulk to the implant, and is typically stiffer than the implant, requiring larger incisions needed and/or holes created within the bodily tissue (for example, double the size). Undesirably large forces may also be required to pull the sleeved implant through a bodily tissue.
Thus, a need exists for a medical device that reduces trauma to the bodily tissue during insertion of an implant, i.e. by reducing the required size of the incision and/or the hole through the tissue. Also, a need exists for a medical device that reduces the force required to move the device through the bodily tissue.